The purpose of the study is to evaluate the efficacy of EGT0001442 in lowering glycosylated Hemoglobin (HbA1c, A laboratory test to diagnose three months average of blood sugar)levels at 24th week from baseline, when compared to placebo group(no diabetic medication given). The secondary aim of the study is to evaluate the efficacy of EGT0001442 in lowering fasting blood glucose at the weeks 2 and 24 and comparing the results with placebo group. This study assess the efficacy of EGT0001442 based on the proportion of subjects who reach the American Diabetes Association (ADA) target of HbA1c of < 7% in EGT0001442 group and comparison with placebo. The study also evaluates the effect of EGT0001442 on systolic, diastolic pressures, body weight and compare with the respective placebo groups.This study also assess the change from baseline in HbA1c overtime, from week 1 to week 96. Finally, to assess the safety of EGT0001442 in the Type 2 Diabetic patients (adult/maturity onset).

EGT0001442 is a compound that may inhibit the effect of other compounds in the body known as sugar transporters. The use of EGT0001442 may enhance the elimination of glucose from the blood by increasing the amount of urine produced. Hence the blood glucose levels are significantly decreased and the efficacy of EGT001442 can be established by assessing the three months average blood glucose levels (HbA1c). Due to the increased urinary output, the effect of EGT001442 on blood pressure levels are also assessed.

Eligibility

Ages Eligible for Study:

18 Years to 70 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Male or female subjects ≥18 years old

Diagnosed with type 2 diabetes

Body mass index (BMI) ≤ 45 kg/m2

HbA1c between 7 and 10% (inclusive) at screening

FPG <250 mg/dL at screening for subjects not treated with oral anti-diabetic therapies or FPG <240 mg/dL at screening for subjects treated with anti-diabetic therapies

Diabetes currently treated with diet and exercise only or diet and exercise along with one approved oral anti-diabetic agent

If taking anti-diabetic medication, dose and regimen must be stable for past 3 months

If taking anti-hypertensive medication, dose and regimen must be stable for past 3 months

If taking lipid modifying therapy, dose and regimen must be stable for past 3 months

Blood glucose <250 mg/dL based on finger stick blood glucose for all subjects at randomization

Exclusion Criteria:

Hemoglobinopathy that affects HbA1c measurement

Current use of injected therapy for treatment of diabetes (insulin or GLP-1 receptor based therapy)

Genitourinary tract infection within 6 weeks of screening

Greater than 2 episodes of genitourinary tract infection in the past year

History of kidney stones, bladder malfunction or other significant risk factor for urinary tract infections

Not willing to use effective birth control, if female with child-bearing potential

Life expectancy < 2 years

New York Heart Association (NYHA) Class 4 heart failure

Sera positive of HCV, HIV, or positive on drug screen

Currently participating in another interventional trial

Previous treatment with EGT0001442 or EGT0001474

Not able to comply with the study scheduled visits

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01377844